MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911424300

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

(b)(6) study.It was reported that myocardial infarction (mi) occurred.In (b)(6) 2012, the patient presented with mi and unstable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in proximal right coronary artery (rca) extending to mid rca with 99% stenosis and was 30mm long with a reference vessel diameter of 4.0mm.The target lesion was treated with direct stent placement of a 3.00x24mm and 3.50x16.00mm promus element¿ plus stents with 0% residual stenosis.After three days, the patient was discharged on aspirin and prasugrel.In (b)(6) 2017, the patient presented to emergency room with complaints of central chest pain.The patient described the chest pain as a stabbing sensation associated with dyspnea on exertion and nausea.The patient also experienced fall at home.Subsequently, patient was hospitalized on the same day for further evaluation.X-ray revealed stable cardiomegaly with mild central pulmonary venous congestion.Electrocardiogram revealed sinus rhythm with frequent premature ventricular complexes and a right bundle branch block.Troponin values were noted to be elevated and site reported an event of mi.The patient received medication therapy in response to the event.Two days later, the event was considered as resolved and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05398 it was further reported that in (b)(6) 2017, 80% discrete in-stent stenosis in mid right coronary artery (rca) was treated with predilatation and placement of 3.5 x 23 non-bsc stent.Following post dilatation the residual stenosis was 0%.Additionally, the patient received medication therapy in response to the event.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7426885
• MDR Text Key: 105364956
• Report Number: 2134265-2018-03130
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: H7493911424300
• Device Catalogue Number: 39114-2430
• Device Lot Number: 15084446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR